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Cerebral Perfusion Variation During Blood Pressure Changes Under General Anesthesia

NCT05803876 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-12-15

No results posted yet for this study

Summary

The risk associated with arterial hypotension during general anesthesia for surgery has been demonstrated , but the threshold at which consequences for perfusion of one or more organs appear varies according to the mechanism of hypotension, associated abnormalities (HR, cardiac output, and oxygen transport), and the patient's terrain.

Currently, a mean arterial pressure greater than 60 mm Hg and a reduction of less than 30-50% from the value measured before general anesthesia are commonly used treatment thresholds to ensure good perfusion of all organs.

Normally, cerebral blood flow is auto-regulated, which allows cerebral blood flow to adapt to oxygen requirements and to different levels of blood pressure, both high and low. However, this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient.

The aim of the study is to measure non-invasively, easily and reliably the variations of cerebral perfusion in patients with and without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during general anesthesia.

What is the target level of blood pressure tolerable for a patient under general anesthesia? Is there a simple and non-invasive way to measure the level of cerebral blood flow autoregulation and especially its adequacy to the brain's oxygen needs?

Conditions

  • General Anesthesia

Interventions

OTHER

Diagnostic test - monitoring

Continuous measurement of blood velocity in the middle cerebral artery by transcranial pulsed Doppler (TCD) Atys Medical TCD-X®. The probe attachment system on the patient's head looks like a pair of glasses; it is light and comfortable. The orientation of the robotic probe is automatically readjusted to ensure stable recording quality over time. (recorded on Data Warehouse Connect). For all patients Vm in (cm/s) will be collected during the adjustment of the mean arterial pressure level between 90% and 70% of the baseline value, without ever going below 60 mmHg for the patients at low risk and 80 mmHg for the patients at high cardiovascular risk.

Sponsors & Collaborators

  • INSERM UMR-942, Paris, France

    collaborator OTHER

  • M3DISIM

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Joaquim MATEO, MD · Assistance Publique - Hôpitaux de Paris

  • Fabrice VALLEE, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2025-07-31
Completion
2025-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05803876 on ClinicalTrials.gov